NCT02168478

Neo-Synalar Modified 48 Hour Patch Test

A Modified 48 Hour Patch Test of Neo-Synalar Cream, Sodium Lauryl Sulfate (Positive Control) and Saline (Negative Control)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Noah Rosenberg, MD · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline). The primary objective of this study is to determine if any subjects exhibit an allergic reaction which may be indicative of a pre-existing sensitization.

Detailed description

Following approximately 48 hours of continuous skin contact, the patch units and test material are removed at the testing facility. The test sites are evaluated for a significant reaction according to the ESS (Erythemal Scoring Scale). The test sites are also re-evaluated at 96 and 168 hours post-application (for late reaction) using the ESS.

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	Neo-Synalar Cream	Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
OTHER	Sodium Lauryl Sulfate Aqueous Solution (0.40%)	Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
OTHER	Saline	Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-06-20
• Last updated: 2015-12-11
• Results posted: 2015-12-11

Locations

1 site across 1 country: United States